First cancer clinical trial approved for Windsor

Dr. Siyaram Pandey is one of the team leaders in Phase 1 of the clinical trials of dandelion root extract as a possible cancer killer. Health Canada approved the trials Friday. (DAN JANISSE/The Windsor Star)

A Windsor-born idea to test dandelion root extract as a possible cancer killer has been approved by Health Canada for clinical trials on humans.

If successful, the findings will spark a “revolutionary change” in the treatment cancer patients receive, according to University of Windsor biochemist Dr. Siyaram Pandey.

“It will change the direction of cancer research in terms of developing new treatment,” said Pandey. “And it will change how we are running towards chemotherapy.”

Phase 1 of the clinical trial was approved by Health Canada Friday, Pandey said. He and Windsor Regional Cancer Centre oncologist Dr. Caroline Hamm had submitted the application in July.
The research began in 2009 when Hamm noticed several patients showed improvements with their cancers after drinking dandelion root tea.

“It started with this 85-year-old lady,” Hamm recalled on Sunday. “She had a very high white blood count of 130 – the normal is about 12. I said to her, ‘There’s not much I could do. I could give you a pill to control it for a while.’ She said to me, ‘Don’t worry about me, I’ll take care of myself.’” The woman returned to Hamm’s clinic three months later. “And her white count was normal – like 10. She said it was dandelion root tea.”

After a few other similar stories from other patients with an aggressive form of leukemia known as chronic myelomonocyctic leukemia (CMML), Hamm called on Pandey to study dandelion root extract in the lab, to better understand why.

Pandey said the evidence seen in petri dishes and test tubes and within cancer-transplanted mice was very surprising.

“This has the potential to induce selective cell death in cancer cells and not in normal cells,” said Pandey.

The results differ from current chemotherapy treatments, where normal cells are damaged during the toxic process of killing cancerous ones.

What was also interesting was that there was no observable toxicity, Pandey added, which may have made it easier for Health Canada to approve the tests on humans.
“One of the reasons why Health Canada was not so much scrutinizing the toxicity is because it is falling under the definition under natural health product or natural extract,” said Padney. This means less risks are involved.

Hamm, who is the principal investigator of the clinical trial, said Phase 1 will be about figuring out the best dose of the dandelion root extract.

“We’ll be escalating the dose with every cohort of patients. So every three patients, we will be giving them a little bit higher dose,” said Hamm. “The goal is to see what the best tolerated dose will be.”

Thirty local patients will be recruited for Phase 1 of the clinical trial. It will be limited to patients with blood cancers or lymph node cancers and will only be tried on those who have already tried chemotherapy and exhausted all other options. These will be patients who are terminally ill with cancers that are drug-resistant.

Both Hamm and Pandey are happy that Health Canada’s approval happened fairly quickly, so that studying the effects of the dandelion root extract can start as soon as possible.

“It is very exciting that it’s moving very fast,” said Hamm. “I think that we’re really lucky to move this forward at this point because it can take a very long time to take clinical observations into clinical trials. Sometimes it can take up to 20 years to make that happen.”

Hamm said this is the first Phase 1 clinical trial for oncology done in Windsor and has gained interest across the nation.

And while the results up to this point are “very promising” within the lab, Pandey is entering Phase 1 with hope, but also caution.

“Now it’s about if it passes the clinical trial – and that’s a very big if. Many things fail in clinical trial,” said Pandey. “Now everything is in the clinicians’ hands and doctors’ hands and we are just keeping our fingers crossed that it works.”

Hamm said although the clinical trial is in its very early stages, it’s an exciting time and she’s hopeful that it will be successful.

“I think even if I don’t see this clinical trial being as a success, it doesn’t mean I don’t believe in the product. There is something there.… There’s no question that I saw improvements in patients when they took this drug,” said Hamm. “If this doesn’t work, I will not be discouraged. And it doesn’t matter if my kids will benefit or if I benefit, as long as we try to keep an open mind that there are benefits that might come out of it.”

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